Thursday, March 28, 2013

The Safe Cosmetics and Personal Care Products Act of 2013 legislation is simply a new premise added onto an old Bill revisiting my industry once again. These proposals have been rewritten so many times the past few years, I have lost count and basically was so sick and tired of all the demagoguery based on mindless supposition and theory, after putting in many hours of research and participation to stop it since it was initiated back in '08, I withdrew from the whole process for a time.

The many different versions fortunately, were so onerous to small manufacturers and with the overreaching regs without scientific evidence to back up the claims offered, it simply couldn't hold any ground for legislators thus far, especially during our economic downturn.

But once again, Jan Schakowsky (D. Ill) and Edward Markey (D. Mass.) are attempting to revive legislation that has been defeated before by creating more regulation based on "no" science evidence but merely, supposition, theory and what we call the "precautionary principle." If we suspect harm, we must ban!

In this newest piece of legislation, these two state Reps are claiming, "it will close major loopholes in the federal law that allows companies to use ingredients in cosmetics and personal care products known to damage human health and the environment.”

Show Me The Science Please!

But to date, there literally has been no peer reviewed science presented to back up the claim; products in our industry have and / or will cause harm to the end user, when the fact of the matter is, they have been used safely for decades. Nor is it any personal care products manufacturers intent to cause harm to the public, let alone use anything remotely toxic for human consumption. Many studies have been published including those by the EPA, which verify and have shown testing on animals, such as mice, does not extrapolate to humans. Furthermore, the dosages are so extremely high in order to cause harm, that no average consumer will ever be exposed to such a dose once, much less over a lifetime. I have provided in previous articles these studies as pertained to past attempts of legislation to over regulate our industry.

At PCT (Personal Care Truth) they have provided a neat breakdown of other attempts of regulations, outlining the major points of the legislation known as H.R.4262 Cosmetics Safety Enhancement Act of 2012 and H.R. 4395 Cosmetic Safety Amendments Act of 2012. These of course never went anywhere, but it bears repeating that this is an ongoing concern for the personal care products and cosmetic industry. Also feel free to further explore PCT for science data and factual research based on evidence only, not fear or paranoia brought about by certain self proclaimed officials (NGO's).

An overview below is an initial outline of what they are trying to accomplish, yet the final draft on this has yet to be seen.

Cosmetic and Ingredient Testing and Safety: FDA would establish a list of ingredients prohibited from being used in cosmetics. This includes carcinogens and reproductive and developmental toxins.

Registration of Cosmetic Companies and Registration Fees: Cosmetics companies would be required to register with FDA and pay a registration fee based on annual gross receipts or sales. Small businesses with less than $2 million in revenues from cosmetics would be exempt from registration; businesses with less than $10 million in revenues from cosmetics would be exempt from registration fees.

Market Restrictions: Provides the FDA with recall authority for products that are misbranded, adulterated, or otherwise fail to meet the safety standard and can request a voluntary recall or order the ceasing of distribution of any such cosmetic product.

Mandatory Reporting of Adverse Health Effects: Cosmetic manufacturers, packagers, and distributors would have to provide the FDA with reports of adverse health effects associated with the use of a cosmetic.

Worker Issues: Requires companies that manufacture cosmetics for salon use to provide information on any health hazards linked with those cosmetics.

States Rights: States may set more stringent standards.

Without seeing the final draft, it is hard to say what direction they are trying to take this, however based on these initial outlines the "States Rights" portion is still problematic.

The Negative Impact This Could Have On Our Industry

Although the entire industry standard has always been about providing safe products for consumers, allowing states to set possibly stricter standards will be far overreaching and detrimental. This is where the incredible, onerous paperwork would begin. My mineral makeup and skincare products are sold globally, yet primarily in the U.S. and to perhaps require me now to have different labeling practices, or different formulating practices, etc. so I can sell to various states...I mean can you imagine? This will make it impossible at not only accomplishing any continued success due to the time an money it will take, but make many entrepreneurs either say "oh forget this" or won't even be able to start up at all due to the financial obligations it will require to accomplish this major task as it is written in the legislation.

California is a prime example and epitomizes the overreach of their state government of continually trying to take away free choice in the market place through a belief of harm when there actually is minimal to none under this context. I have many customers in this state who love our products and with the stroke of the pen over an ideology of something they deem hazardous without science or by ignoring it, can literally prevent customers in this state from further receiving our products if they are determined to target the latest ingredient as unsafe, whatever it may be. In fact, Titanium Dioxide is under consideration for being added to Prop. 65. This is a main sun blocking agent found in the majority of mineral makeup products.

Other states can follow similar legislation if the current legislation above is passed. This is not a question as to me being overly concerned since this is no joke or something I am just bloviating about. Simply refer to the Dunkin' Donuts issue over something as simple as Coffee and the natural constituent it has within the coffee bean, known as "Acrylamide". This article is quite telling and other links are provided with continued research done and the conclusions to that research. Basically, the Swedish study was overblown and inaccurate, yet look at the harm it caused multiple industries in the state of California.

Starbucks and other food companies were sued as well over this ingredient and labeling practices based on how their current legislation reads, allowing zealots to become litigious even without any proof of harm or without even using the product, just based on a label they research and finding noncompliance.

Acrylamide isn't added, but is naturally occurring, and coffee has been shown in multiple studies as to its' many health benefits, such as reducing stroke, colon cancer, heart disease and many other forms of cancer. This type of targeting of ingredients based on theory rather than on the practicality or science of products we have used for generations, safely, is unfortunate for many consumers. Frankly, I'll keep drinking my cup of Joe for the health benefits it is proven to provide to the coffee drinker.

Food Police....Just The Real Facts (Science) Please

There are certainly many foods you may want to avoid with elevated levels of this constituent if you are concerned, but to avoid it overall in our diets, is next to impossible, especially when this ingredient is also found in lower levels in Apples, Broccoli, Asparagus, Green Beans, Spinach, Cherries, Carrots, Onions, Potatoes, Olives, Cocoa (chocolate), Plums and Prunes, to name a short list. Should we ignore the obvious health benefits of these foods to override undue fear of a tiny amount of constituent they contain?.....

I pause and wonder, why are food growers exempt from having this label? Clearly there is a certain amount of hypocrisy in these regs. So basically, you can eat the food containing lead or acrylamide under Prop 65, but you can't use it in a skincare product without testing it first for the safe levels allowed, or you must place the prop 65 warning label on the item. Last I checked, ingesting a chemical of concern is far more likely to cause harm than smearing it on your skin which is actually an impermeable barrier to protect the body. When it comes to our government, this type of obtuse thinking has absolutely baffled me.

Let me state however, most of the foods with elevated levels of Acrylamide, we shouldn't be eating anyway based on the other well known health problems they cause with consumption of these same foods. Some interesting facts and figures about this constituent and how it is formed are in the links below:

I believe that Prop. 65 was headed in the right direction for a safer environment and to reduce hazardous chemical use when it was created back in 1986, and I am all in for reducing environmental toxins, but only unless and until the scientific evidence supports the objective. But unfortunately, through the proposals and passing of amendments of the original legislation, pushed by power hungry, ambitious NGO's, unscrupulous parties have exploited Prop. 65 by those wanting to make a buck or push an environmental agenda against certain ingredients which can also contain constituents in question, and then trying to extrapolate harm through a theory rather than from actual science.

Basically, to show a further example as it relates to this latest cosmetic and personal care products act; acrylamide can be found in cocoa butter which is used in many skincare products for application on the skin. So because of Prop. 65, as I understand it, if this ingredient along with its' constituent is being used, supposedly a warning label is required on the product in the state of California which reads:

And any amount seems to trigger the Prop. 65 regulation. Again, an ingredient applied to the skin does not extrapolate to causing harm or injury of similar in the same way as something we may ingest or inhale, but the personal care product containing a questionable ingredient would be affected nonetheless based on California mandate. For me, this is government run amok beyond best intentions. And it worries me to say the least since my wonderful customers in California and others should this spread federally, could have their personal choice be removed of enjoying the many benefits our mineral makeup and skincare products offer to the consumer.

On Google images you can view a virtual sea of Prop. 65 warning labels as they pertain to many industries. After looking at these, it strikes me as odd that California State Legislators are declaring some sort of omnipotence over its citizens as to what is best for all, and overkill on warning about the possibility of harm which in turn will more than likely create an apathetic public due to this bombardment. Basically becoming ineffectual! Consumers will want what they want and will recognize the absurdity this has become based on how Prop. 65 went from a good cause to being grossly abused.....but the final question is, at what cost to everyone?

Key Points Of Why Legislation Similar to Prop 65 Would Cause Undue Hardship To Small Business

For one, putting the warning label on a product is not required if the amount of the identified hazardous chemical is below the danger level. But, without the government’s classification of the allowable level, it is the business’ responsibility to find out what the level is using acceptable scientific methods. This would mean additional expense and effort for the business owner. This alone would add cost to products which will be passed on to the consumer or wipe out the business altogether if this cost is absorbed by the company. Ultimately this is a lose, lose proposition.

Secondly, when a certain product has the warning sign, it may be because the manufacturer chose to put it on due to the chemical being actually present, even without verifying if it has exceeded the safe level or if it may even be zero. The business owner would rather include the warning rather than risk violating the law or spending effort and money to determine a chemical’s safety level. Also a tact they may choose to implement in order to avoid being sued by litigators who have nothing better to do than destroy cottage industry.

Thirdly, it is not a violation of Prop 65 to post a warning, however unnecessary. These warning signs have become so commonplace that consumers don’t take notice anymore and it loses its purpose to educate and inform them. Hence the reason they are now ineffectual to say the least and consumer safety is not actually improved at all.

Fourthly, now instead of growing a business or working on creation of personal care and cosmetic products, onerous research and inordinate amounts of time will be spent keeping tabs on all 50 states making sure they have not added some new piece of legislation or named some new chemical or its' constituent, whether it be synthetic or natural, to the list deemed unsafe or causing harm. Without this knowledge, a company could end up being in noncompliance. Remember Dunkin' Donuts?

Beyond Comprehension

Maybe it's just me, but when I see states legalizing Marijuana and people treating it like the next best thing since McDonalds, basically ignoring and violating federal law themselves, but yet legislators want federal law with this latest proposed upcoming legislation, stipulating states can impose stricter regulations, it just seems to me our state and federal governments don't have a clue.

They only seem to do what feels good at the moment instead of comprehending the all encompassing ramifications this type of regulation will cause to many entrepreneurs and consumers alike. And quite frankly, I am at a loss ....yet still believe, allow the consumer to choose best for their families with their hard earned dollar. Stop over regulating job creators right out of business or policing our decisions as to which products to buy by eliminating them altogether through overreaching regulation..... that is NOT Consumer Freedom!

The LA Times wrote an article about Prop 65 showing two sides of this argument and attorney Lisa Halko has it correct. She clearly shows the argument with the problem of targeting constituents of an ingredient (natural or otherwise as natural products will not be exempt) or foodstuff and this is what the personal care products and cosmetic industry as a whole knows will come to pass at a federal level.

Rep. Markey's and Rep. Schakowsky's are proponents for the law, yet their ongoing proposals and statements are full of innuendo and as overstated as they are, in my opinion, are designed to scare consumers since I reiterate......Where is the SCIENCE? And as consumers, we too should be demanding they show us the science, not base an entire summary of harm on the "precautionary principle."

Until the final draft, the key points listed look tame initially, but review the links above on past proposed legislation to see how onerous and out of touch this legislation would have been as it relates to financial harm. And the drafts were created out of skewed science and research provided by NGO's such as the Environmental Working Group and The Campaign for Safe Cosmetics to create hyperbole. It has been these sister organizations M.O. to find and locate and then cherry pick a non peer reviewed single study, twist it and use it for their financial gain, ignoring all other actual peer reviewed research studies which refute the Swedish study, such as Acrylamide shown in the Dunkin' Donuts link above, since the true and correct science would not fit with their agenda. Scaring consumers is big business and business is GOOD it seems!

With each passing day of new regulations becoming commonplace, our government contributes to a stifling environment not conducive to the needs and growth of small businesses anymore. They literally are making it more difficult to next to impossible for start-ups to even gain a foothold, and the future of our industry is in the proverbial cross hairs of our federal and state legislators as I conclude this article. (sigh)

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